Tetra Bio-Pharma provides USA regulatory update for its cannabis inhalation product.
PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc., is a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announced that the development of its smoked marijuana prescription drug is on schedule.
The company confirmed that, on November 8, 2016, it received a letter from the Office of Combination Products stating that the U.S. Food and Drug Administration (FDA) had completed its review of the request for designation for the marijuana prescription drug and titanium pipe kit. The FDA confirmed that the product is a combination product, and assigned it to the Center for Drug Evaluation and Research (CDER) as the lead agency center for premarket review and regulation based on FDA’s determination of the marijuana product’s primary mode of action.
The company previously announced that it received a pre-IND (Investigational New Drug) acknowledgement and meeting request granted letter from the U.S. FDA. This week, the company is submitting the information package required by FDA for the Type B pre-IND meeting in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research.
According to Dr. G. Chamberland, chief science officer, “As per FDA policies, the pre-IND information package is submitted to obtain guidance from FDA on the product development and marketing requirements for the smoked marijuana prescription drug combination product”. Chamberland further commented that this regulatory filing is part of PPP’s dedication to the commercialization of marijuana as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.
The company has been working with Algorithme Pharma, an Altasciences company, for the conduct of its Phase I clinical trial in healthy human subjects. PPP is using the services of Algorithme Pharma based on its experience and expertise in the conduct of clinical trials for the pharmaceutical industry. Later this week the project team will be submitting the Phase I clinical protocol, and related documents, to the Institutional Review Board for review. If approved, Algorithme Pharma will subsequently submit the Clinical Trial Application to the Therapeutic Products Directorate of Health Canada for approval. In parallel, Algorithme Pharma will submit an application for exemption under section 56 of the Controlled Drugs and Substances Act for its planned research on healthy subjects.
The Company stated that, subsequent to a request for classification to the Medical Devices Bureau, Health Canada, the PPP001-titanium pipe that will be used in the clinical trial is a Class I medical device. Chamberland commented: “As a Class I medical device, the PPP001-titanium pipe does not require approval for use in the clinical trial”.
The PPP001-kit product will be sold as two separate products packaged together in a single package and is comprised of the drug PPP001 and the device PPP001-titanium pipe. The drug component and device component will be linked together by the labelling of each component.
The product PPP001-kit, once approved, could be sold in pharmacies containing the prescription controlled drugPPP001, in a blister pack, and the PPP-titanium pipe device that will be used to generate the smoke to deliver the active ingredients by inhalation.
PPP001 drug pellet blisters and a fully assembled PPP-titanium pipe for combustion and inhalation of the generated smoke are required for therapy with PPP001 and are provided in the PPP001-kit.
Each blister of PPP001 drug pellet contains marijuana with a standardized amount of delta-9-tetrahydrocannibinol and cannibidiol. A single PPP001 drug pellet is pushed out of the blister by the patient and inserted into the PPP-titanium pipe.